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(B) The quantity While using the unit of evaluate (such as ranges or suggests, acceptance boundaries) of each and every tobacco component within the tobacco product documented as mass per gram of tobacco for nonportioned tobacco products and solutions and as mass per part for portioned tobacco items (with any specification variation, if applicable)

clinical studies that assess authentic-globe use conditions and wellbeing results, or clinical studies that use scientifically legitimate endpoints like a predictor for opportunity lengthy-time period health outcomes). Wherever a PMTA lacks human topic research info regarding the merchandise or that may be bridged towards the products, FDA will ana